UK MHRA

Registration with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.

📋 Regulatory Details

Device Name TeltoHeart	Trade Name TeltoHeart
Device Type Physiologic Monitor / Medical Device Software	GMDN Code 66625 Physiologic Monitor – Installed Software
UK Medical Device Classification Class IIb	Applicable Regulation UK Medical Devices Regulations 2002

📄 Declaration of Conformity

We, UAB Teltonika Telemedic, being the manufacturer of the above-mentioned medical device, declare under our sole responsibility that the device complies with the applicable requirements of the UK Medical Devices Regulations 2002.

🇬🇧 MHRA Registration Information

The device is registered with the Medicines and Healthcare products Regulatory Agency (MHRA):

MHRA Reference Number 33173	Date Registered 23/10/2024
Manufacturer UAB Teltonika Telemedic	Manufacturer Address Ukmergės g. 120-1, Vilnius, Lithuania LT-08126
Customer Service Email Not Available	Customer Service Telephone Number Not Available
UK Responsible Person / NI Authorised Representative Teltonika United Kingdom Ltd	Relationship UK Responsible Person
Representative Address Suite G1, Building 8 Quay Exchange, Salford, England, United Kingdom M5 3EJ	Device Brand / Trade Name TeltoHeart
GMDN® Code 66625	Device Registration Status Registered
Medical Device Risk Classification Class IIb